Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC, a consulting firm specializing in China CFDA regulatory, CRO and market access services.
- CFDA issued “Innovative Medical Device Special Approval Procedures (Revised Draft for Feedback)”. Within 60 days after the application is received by CFDA, the agency will notify the applicant whether the application has been approved.
- Hainan provincial government published “Regulation for Urgently Needed Imported Medical Devices in Hainan”. Before CFDA registration approval, imported medical device can be clinically used in qualified healthcare facilities.
For English version of the above documents, please email info@ChinaMedDevice.com.
CFDA issued 2 guidelines on May 11:
- pre-clinical trial guideline on coronary drug-eluting stent
- clinical trial guideline on coronary drug-eluting stent
CFDA announced recall notices to 5 medical devices from 4 foreign manufactures and 1 domestic one. Foreign manufacturers include:
- GE: x-ray bone density detector
- Becton Dickinson: vacuum blood collection tube
- Smith & Nephew: 1) external fixation system 2) RF plasma surgery system
- Magellan: blood lead analyzer
About China Med Device, LLC
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ companies’ success.